Scenario: A doctor is about to inject an aseptically manufactured injectable finished pharmaceutical into the arm of a child.

1. How would you convince both the patient’s parents and the doctor that the manufacturing process was robust and to proceed in confidence with the administration?
2. What are the biggest risks to the child?
3. How are they controlled?

Question 2:

Examine the graphical representation on the next page for “A Validation Approach for a Complex Project, Consisting of Many Systems and Components”.

1. In terms of “Qualification Rationale”, describe the process of a system-impact-assessment and component-level-impact assessment.
2. In your own words define the term installation qualification (IQ).
3. In your own words define the term operational qualification (OQ).
4. In your own words define the term performance qualification (IQ).

Briefly describe the inter-relationships between the following operational activities for a computerized system in a GxP environment.

1. Handover
2. Establishing and Managing Support Services
3. Performance Monitoring
4. Incident Management
5. Corrective and Preventive Action
6. Operational Change and Configuration Management
7. Repair Activity
8. Periodic Review
9. Backup and Restore
10. Business Continuity Management
11. Security Management
12. System Administration
13. Archiving and Retrieval

Question 4:

Examine the diagram on the next page for a typical vertical processing facility designed for batch API production.

Describe, with reference to the diagram, how synthetic API plants (Batch Organic Chemical Synthesis) normally follow a sequence to produce a solid product:

1. Reaction (Continuously Stirred Tank Reactor (CSTR))
2. Crystallization
3. Separation
4. Drying

Question 5:

Study the following diagram that represents the basic unit operations that most companies implement when manufacturing a biopharmaceutical protein-based drug substance.

Briefly describe the following three stages of a typical process:

1. Stage I: Upstream Processing
2. Stage II: Fermentation
3. Stage III: Downstream Processing

Question 6:

Describe the principals for a typical cleaning validation sequence as listed below:

1. Use the equipment for the process
2. After processing hold the equipment and allow to dry
3. Clean as per the procedure
4. Sample for product residue, cleaning-agent residues, and others
5. Repeat twice more, giving three (3) consecutive runs
6. Develop on post-cleaning monitoring strategies

Question 7:

Describe the primary process principals of a typical pharmaceutical tableting operation. List three (3) critical parameters that must be controlled.

Question 8:

Combining the principals of the FDA’s approach to medical device classifications with the EU Medical Device Directive 93/42/EEC, list three devices in the following categories giving reasons for your answers:

1. Class I
2. Class II (or IIa / IIb)
3. Class III